Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/02—Surgical instruments, devices or methods for holding wounds open, e.g. retractors; Tractors
  • A61B17/025—Joint distractors
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/02—Surgical instruments, devices or methods for holding wounds open, e.g. retractors; Tractors
  • A61B17/0206—Surgical instruments, devices or methods for holding wounds open, e.g. retractors; Tractors with antagonistic arms as supports for retractor elements
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/28—Surgical forceps
  • A61B17/2812—Surgical forceps with a single pivotal connection
  • A61B17/282—Jaws
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B2017/00831—Material properties
  • A61B2017/00902—Material properties transparent or translucent
  • A61B2017/00915—Material properties transparent or translucent for radioactive radiation
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B2017/00831—Material properties
  • A61B2017/00902—Material properties transparent or translucent
  • A61B2017/00915—Material properties transparent or translucent for radioactive radiation
  • A61B2017/0092—Material properties transparent or translucent for radioactive radiation for X-rays
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/02—Surgical instruments, devices or methods for holding wounds open, e.g. retractors; Tractors
  • A61B17/025—Joint distractors
  • A61B2017/0256—Joint distractors for the spine
• • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
  • F04—POSITIVE - DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS FOR LIQUIDS OR ELASTIC FLUIDS
  • F04C—ROTARY-PISTON, OR OSCILLATING-PISTON, POSITIVE-DISPLACEMENT MACHINES FOR LIQUIDS; ROTARY-PISTON, OR OSCILLATING-PISTON, POSITIVE-DISPLACEMENT PUMPS
  • F04C2270/00—Control; Monitoring or safety arrangements
  • F04C2270/04—Force
  • F04C2270/042—Force radial
  • F04C2270/0421—Controlled or regulated

Definitions

• a surgical retractor includes an elongate element defining as operational axis.
• a first blade having a first blade face, is secured to the eiongate element.
• a second blade defining an ' opening is moveab!y secured to the elongate element and defines a reference point thereon. Movement of the second blade moves the reference point in a linear direction generally parallel to the operational axis and generally orthogonal to the blade face.
• a guide element is removably received within the opening.
• a method of performing spinal surgery using a lateral approach includes inserting a guide element into a first location above a ' target surgical site, and repositioning the guide element into a second location above the target surgical site.
• the second location may be more posterior than the first location.
• the method includes inserting a retractor device alon the guide element, with the retractor device having first and second retractor blades that are inserted al ong onl y a first si de of the guide element.
• the first retractor blade is anchored to the target surgical site.
• the method includes separating the first and second retractor blades by moving the second retractor blade away f om the first retracto blade, and locking the .first and second retractor blades to maintain an open access to the target surgical site.
• FI G. 1. depicts a perspective view of a retractor system.
• FIG. 2 depicts perspective views of a guide element insertion device.
• FIGS. 3 A and 3B depict a top view and a side view, respectively, a retractor device.
• FIG. 4 depicts a side view of a retractor system.
• FIGS. 5 A and 5B depict enlarged partial perspective views of a retractor blades.
• FIGS. 6 A and 6B depict perspective views of a retractor device.
• FIG. 7 depicts a method of using a retractor system.
• FIG. 1 depicts a retractor system 100 that includes, generally* a retractor device 102, a auide element 104, and a driver 106.
• the retractor device 102 includes a handle 108 coupled to an- elongate element 110 to which two blades 1 18, 120 are secured.
• the handle 108 is a removable handle that is selectively coupled to or removed from the elongate element 1 10.
• the blades 1 18, 120 may be secured directly io the elongate- element 110 or secured with one or more armatures 114, 1 16. s shown in FIG. 1 , in one embodiment, the armatures !
• the driver 106 is used to actuate a moving mechanism, in this case, to rotate a gear that engages with a rack along the elongate element 110, Actuation of the moving mechanism can operate to separate the armatares 114, 116, and thus separate the blades 118, 120. This mechanism is more clearly depicted in FIG. 3B.
• One of the retractor blades 1 18, 120 defines an opening for receipt of the elongate guide element 104 , the- use of which is described below. Additionally, one or both of the blades 118. 120 may be configured to removably receive one or more shims.
• the guide element 104 and a guide element insertion device 202 are depicted in FIG. 2.
• the guide element 104 is an elongate dissector having a generally D-shaped profile, although the present disclosure contemplates other elongated dissector profile shapes, including elliptical, trapezoidal, oblong, triangular, and the like.
• the blunt tip 204 and profile shape of the guide element 104 simplifies the .insertion process and also assists in ' splitting the psoas along the plane of the muscle fibers.
• a probe 206 may be placed in a channel 206a or opening extending lengthwise along the guide element 104.
• a K ⁇ wire can be placed via the same or a second channel to dock the guide element 104 to the disc space.
• the K-wire may be already inserted into the guide elemen 104, prior to the guide element 1 4 being inserted.
• This opening 10 may be a fully closed channel, a partially closed channel, or some combination thereof.
• the - wire channel 210 may be located in or on the guide element 104 (as shown), is armature 1 14 or armature 116, or in an anterior retractor blade 1 1 S or a posterior retractor blade 120.
• the guide element 104 may include a number of notches 214 that provide an engagement surface for an insertion device 202.
• forceps including radio-lucent arms 212 are used for insertion.
• Other types of insertion devices may be used, or the guide element 1 4 may also be positioned by hand, if desired.
• the . radio-lucent forceps arms 212 typically will not show during fluoroscopy, but radio-opaque markers 208 may be included on the .arms 202 to assist in positioning. Radio-opaque markers 208 placed at other locations indicating the positions locations of certain elements may be utilized.
• the guide element 104 may also be radio-lucent Radio-opaque markers also may he positioned proximate the center and anterior border of an implant to be inserted during the surgical procedure.
• FIGS. 3A-3B depict various views of a dissector-type guide element 104 used, in conjunction with a retractor device 102.
• the driver is used to actuate a moving mechanism, in th s case, to rotate a gear 302 that engages with a rack 304 along the elongate element 110.
• a locking element 302a may prevent further movement of the gear when engaged, by for example, engaging the rack 304.
• the guide element 104 is received within an opening 306 defined by at least one of the retractor blades 118, 120. in the depicted embodiment, the opening 306 is located in the posterior blade 1.20.
• an opening 306 may be located in the anterior blade 1 1.8 or in either or both of the armatures 114, 116.
• the retractor device 102 is moved M along an axis A so as to receive the guide element 104 in the opening 306.
• the flat portion of the generally D- shaped guide element 104 is facing anteriorly (i.e., towards the blades 118, 120), such that the retractor device 102 is slid over the guide element 104 with the face surfaces of the opposing retractor blades 1 I S, 120 facing each other. Since the guide element 104 is located in the opening 306 defined in the exterior surface of the posterior blade 120, all or substantially all of both blades 1 18, 120 are located on the same side of the guide element 104, unlike
• FIG. 3 A depicts a distal end 310 of the posterior retractor blade 120, along with the guide element 104 located along a rear s urface of the blade 120.
• the distal ends 310 of the retractor blades 118 120 should not be inserted lower than, the ti 204 of the guide element 104, but the blades 1 18, 120 may be inserted further, if desired,
• FIG. 3B also depicts the retractor lock 302a, which is used to fix the position of the posterior blade armature 1 16 along the elongate element 11 and to prevent inadvertent movement of the armature 1 16, and therefore the blade 120, along the ⁇ elongate element 1 10.
• the retractor lock 302a may be disengaged prior to rotating the gear .302 with the driver 106, as described above in the context of FIG. 1.
• the retractor lock 302a then may be reengaged to preven further movement of the armature 1 16,
• the retractor lock 302a may engage with the elongate element 1 10, either at the rack 304 itself or at a separate point located on the elongate element 1 10.
• an articulating arm (not shown) may be connected to either the anterior blade armature 1 14 or the posterior blade armature 116, An opposite end of the articulating arm is connected to a fixed point (typically on the operating table), to hold the retractor device 102 in position during operation of the opening mechanism.
• actuation of the opening mechanism will move the posterior blade 120 along the.
• the two-blade, flat-blade design assists in splitting the psoas muscle along the plane of the muscle fibers, thereby red ucing trauma
• either or both of the blades 118, 120 may be configured with- any number of openings, channels, or other structures that allow for receipt of an electrode pro be, suc thai die location, of nerves may be determined during Insertion of the retractor device 102, during opening of the bl ades .118, 120, or after opening of the blades 1 I S, 120. Use of such probes for identifying nerve proximity and direction is well-known: within the field of spinal surgery, and will not be further described herein. Additionally, the same or other channels may be used to hold a light source used to illuminate the surgical corridor.
• FIG. 4 depicts a partial side view of the retractor system 100.
• the retractor blades 118, 120 of the device may be fitted with one or more shims tha serve particular purposes during surgery. Widening shims may be used to help ensure muscle tissue does not encroach on the surgical corridor. Lengthening shims may be used to effectively lengthen the depth, of penetration of the blades 1 18, 120. Intradiseal shims may be used to penetrate the disc space of the spine so as to access the disc and hold one of the blades 118, 120 of the retractor device 102 in place, relative to the spine. As depicted in FIG.
• FIGS. 5A and 5B depict a wrap-around shim 502 and an internally-confined shim 504, respectively.
• Either shim 122 type may be used in conjunction with the retracto device 302, on either or both of the anterior blade 118 and the posterior blade 120.
• Either shim 502, 504 may include a ratchet 506 that engages with a rack 50S located on the blade 120, such that the s im 502, 504 may be inserted to a desired depth and held in place.
• Both of the shims 502, 504 depicted in FIGS, 5 A and 5B are intradiseal shims that include a tip 510 that ma be inserted into the disc space, to help fix the location of the blade 120 internal to the body.
• the rack 508 may extend along a portion of an inner channel S 12 of the blade 118, 120, or may extend the entire length of the inner channel 512,
• FIGS, 6A-6B depict the .embodiment of the retractor device 102 shown in an open position, creating a surgical corridor within the muscle tissue.
• a functional surgical corridor need not require the blades 118, 120 to be opened to a maximum distance.
• a frame 612 may be placed between the blades 118, 120 to provide support to the distal ends 310 of the blades 1 18, 120. This ma be useful, for example, should the surrounding tissue force an inward deflection of the blade ends 3.1 and thus cause a narrowing of the surgical corridor.
• FIGS. 6A and 6B also depict a lengthening shim 614 located on. the anterior blade 1 1 S.
• the elongate element 110 defines an operational axis G.
• Each front face of the anterior blade 1 18 and the posterior blade 120 define a plane. For clarity, only anterior plane P is depicted in FIG, 6A.
• Each of the blades 118, 120 also includes a reference point 606 located thereon.
• the reference point 606 may be located on the face surface 602 or rear surface 604 of the blade, or may be a defined point thereon, for example, a center of gravity, a blade tip, a radio-opaque .reference point, etc. Additionally, the reference point 606 need not be a distinct physical point.
• a predetermined reference point 606 is identified on the rear surface 604 of the posterior blade 120 in FIG. 6 A, Fo the purposes of this example, the articulating arm described above is connected to the ailterior blade armature 114. Therefore, as the moving mechanism (the gear 302) is operated, the posterior blade 120 moves toward the handle 108. In thai regard, the reference point 606 moves along an axis of movement M that is generally parallel to the operational axis O and generally orthogonal to the anterior blade plane P.
• the articulating arm is connected to the posterior bl ade armature 116, similar movement of the anterior blade 1 18 occurs.
• a reference point located on the anterior blade 1 IS moves along an axis generally parallel to the operational axis O, as well as generally orthogonal to the posterior blade plane.
• the intradiscal shim 504 depicted may be inserted into the intradiscal space to help further limit movement of the posterior blade 120.
• the tip 510 of the intradiscal shim 504 is not extended beyond the blade tip 310 during movement of the blade 118, 120 on which the intradiscal shim 504 is installed.
• FIG. 7 depicts a method 700 of using a retractor system, in a surgical procedure.
• the method is described in the context of lateral- approach spinal surgery, it should be noted that the systems and methods described herein may be used in virtually any surgery where limited muscular and/or nerve trauma is desired, In surgeries where limited, controlled separation of muscle fibers ' is desirable, the retractor system described herein may be particularly advantageous.
• method 700 can combine Operations or eliminate operations altogether. For example, operations related to nerve monitoring and probes may be omitted in the event the surgeon does not elect to use nerve monitoring.
• a guide element is inserted (operation 702) into fee area of aus (in this ease, the psoas muscle) and directed toward the target tissue, organ, or skeletal structure ( i this ease a vertebrae or disc space).
• An electrode probe may be located in the guide element prior to insertion and introduced at the same time as the guide element.
• the probe may then.be energized and the feedback monitored (operation 704) to check for nerve response (e.g., in the .lumbar plexus).
• the guide element is positioned so as to be centered near the anterior one-third of the intravertebral disc.
• the guide element may be repositioned (operation 706) as required or desired, generally until a suitable location is found.
• Electrode monitoring may be repeated to confirm the location is safe for the surgery to continue.
• the guide element is repositioned (operation 706) posteriorly in small increments until the desired locaiion is found and nerve monitoring indicates the locaiion is safe for surgery to continue.
• the guide element is positioned as far posterior as possible, so that subsequent retractor blade movement w ll be a movement of only the anterior blade away from the posterior blade.
• the guide element may be swept (operation 708 ⁇ side-to-side so as to create a plane in the psoas muscle and make an initial opening into which a retractor device will be inserted.
• a K-wire may be inserted (operation 710) via the guide element toward the target region, and secured relative to the disc space.
• the monitoring probe may be removed (operation 712) from the gui de elemen t and inserted into one of the retractor blades. This wo uld allow for monitoring o f nerve response during insertion of the .retractor, which may be desirable in certain situations.
• a second monitoring probe may be used with the retractor.
• the retractor blades are inserted on the same side of the guide element, into the opening formed by the earlier sweeping movement thereof. As described above, this helps separate the psoas muscle along the muscle fibers. Additionally, by inserting both blades on the same side of the guide element, the guide element can be positioned on the posterio side of the desired surgical site, with the posterior blade also being positioned on the posterior side of the desired surgical site.
• the guide element is inserted into the opening defined by the retractor blade, typically the posterior retractor blade.
• the probe may be energized and the feedback monitored to confirm location and or proximity of the blades relative to nearby nerves (operation 716). This blade position monitoring operation 716 need not be performed however. Regardless, once the retractor blades reach their desired
• an articulating arm may be connected (operation 718) to either of the posterior blade armature and the anterior blade armature.
• connection to either of the armatures will dictate which of the armatures moves and, accordingly; the direction of separation of the retractor blades, (i.e., anteriorly or posteriorly).
• a number of different actions may be taken in virtually any order to complete the surgical procedure.
• the blades may be spread slightly and a shim may be inserted (operation 720).
• a shim may accomplish any of the purposes described above, and in one embodiment is used to further anchor the distal end of one of the blades to help seeure it place relative to a desired surgical site.
• the blades may be spread further and a frame may be inserted (operation 722) to provide rigidity to the distal ends of the retractor blades. Again, this blade separation may occur from just single blade moving while the other bl de remains generall in place.
• surgical procedures may be performed (operation 724), such as a partial or full discectomy, and insertio -of an implant per the surgeon' s discretion.
• surgical procedures may be performed at any time after insertion of the blades, and the shims and/or the frame may be inserted at any time during the procedure, as required. For example, if a surgical procedure is initiated without insertion of a frame, but during the procedure, the surgical corridor begins to contract, the surgeon may then insert the shim and/or the frame. Additionally, the locking mechanism ma be locked and unlocked as required during the procedure.
• Materials utilized in the manufacture of the retractor system may be those typicall used in surgical equipment. Stainless steel titanium, and other robust metals that may be sterilized may be used. In applications where fluoroscopy is desirable or required during the procedure (e.g., in the spinal surgery procedures described herein), radio-lucent materials may be particularly desirable, in those applications, aluminum, anodized aluminum, and rigid polymers may be utilized. Carbon fiber-reinforced polymers may be particular useful, as they are
• radio-lucent materials may be used for the blades and less expensive radio-opaque material may be utilized for the elongate element and armatures.
• radio-lucent materials may be impregnated in discrete locations with radio-opaque materials such that position of certain parts of the system may be visible during procedures, without impeding overall visibility.

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• Health & Medical Sciences (AREA)
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• Surgery (AREA)
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• Animal Behavior & Ethology (AREA)
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• Ophthalmology & Optometry (AREA)
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• 2012
  • 2012-08-17 WO PCT/US2012/051480 patent/WO2013028571A1/en not_active Ceased
  • 2012-08-17 JP JP2014526262A patent/JP6073889B2/ja active Active
  • 2012-08-17 AU AU2012299061A patent/AU2012299061B2/en not_active Ceased
  • 2012-08-17 CA CA2845332A patent/CA2845332A1/en not_active Abandoned
  • 2012-08-17 US US14/239,528 patent/US10166018B2/en active Active
  • 2012-08-17 CN CN201280044606.4A patent/CN103987326B/zh active Active
  • 2012-08-17 EP EP12826211.0A patent/EP2744421B1/de active Active
• 2018
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• 2021
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• 2025
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